Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Completed · Phase 3 · Has a placebo group

Conditions studied: Paget's Disease of Bone

In brief

The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.

Key facts

Study ID

NCT00051636

Run by

Novartis Pharmaceuticals

People needed

172

Starts

2001-01-01

Expected to finish

2011-04-01

Last updated by the study team

2012-05-15

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 30 years or older
• Serum alkaline phosphatase (SAP) 2 times upper limit normal (ULN)
• Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).
• 90 days washout calcitonin
• 180 day washout bisphosphonate

You may not qualify if…

• Allergic reaction to bisphosphonates
• History of upper gastrointestinal disorders
• History of iritis, uveitis
• Calculated creatinine clearance < 30 ml/min at baseline
• Evidence of vitamin D deficiency
• Other protocol-defined inclusion/exclusion criteria applied.

Where it is running

• Novartis Investigative Site — Santa Monica, California, United States
• Novartis Investigative Site — Lakewood, Colorado, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative site — Maywood, Illinois, United States
• Novartis investigative site — Worcester, Massachusetts, United States
• Novartis investigative site — Detroit, Michigan, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis investigative site — Syracuse, New York, United States
• Novartis investigative site — Durham, North Carolina, United States
• Novartis investigative site — Medford, Oregon, United States
• Novartis investigative site — Providence, Rhode Island, United States
• Novartis Investigative Site — Concord, Australia
• Novartis Investigative Site — Fitzroy, Australia
• Novartis Investigative site — Geelong, Australia
• Novartis Investigative Site — Kogarah, Australia
• Novartis Investigative site — Maroochydore, Australia
• Novartis Investigative site — Nedlands, Australia
• Novartis Investigative Site — Calgary, Canada
• Novartis Investigative Site — London, Canada
• Novartis Investigative Site — Montreal, Canada
• Novartis Investigative Site — Ste-Foy, Canada
• Novartis Investigative Site — Toronto, Canada
• Novartis Investigative site — Auckland, New Zealand
• Novartis Investigative Site — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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